Non-Small Cell Lung Cancer Coverage from Every Angle

Atezolizumab vs Docetaxel in Patients With Previously Treated NSCLC (OAK): A Phase 3, Open-Label, Multicentre Randomised Controlled Trial

Results of the phase 3 OAK trial support the late 2016 approval of atezolizumab in patients with metastatic NSCLC who have received prior platinum-containing therapy: treatment with the anti–programmed cell death ligand 1 (PD-L1) antibody improved overall survival vs docetaxel, regardless of PD-L1 expression or histology, with a favorable safety profile.

The co-primary endpoints were overall survival in the intention-to-treat population and in the population with ≥ 1% PD-L1 expression on tumor cells or tumor-infiltrating immune cells.

Among all patients in the primary analysis of the intention-to-treat population, median overall survival was 13.8 months in the atezolizumab group vs 9.6 months in the docetaxel group (hazard ratio [HR] = 0.73, P = .0003).

Median overall survival was also improved with atezolizumab among patients with low or undetectable PD-L1 expression (12.6 months vs 8.9 months, HR = 0.75, 95% confidence interval [CI] = 0.59–0.96). Among 112 atezolizumab patients and 110 docetaxel patients with squamous histology, median overall survival was 8.9 vs 7.7 months (HR = 0.73, 95% CI = 0.54–0.98). Among 313 and 315 patients with nonsquamous histology, median overall survival was 15.6 vs 11.2 months (HR = 0.73, 95% CI = 0.60–0.89).

Median progression-free survival was 2.8 months in the atezolizumab group vs 4.0 months in the docetaxel group (HR = 0.95, 95% CI = 0.82–1.10). Objective response was observed in 14% vs 13%; median duration of response was 16.3 vs 6.2 months.

The most common adverse events of any grade that were ≥ 5% more common with atezolizumab were musculoskeletal pain and pruritus; those adverse events more common with docetaxel included fatigue, alopecia, diarrhea, and anemia. Treatment-related adverse events of any grade occurred in 64% of those in the atezolizumab group vs 86% of those in the docetaxel group, with the most common in the atezolizumab group being fatigue (14%), nausea (9%), decreased appetite (9%), and asthenia (8%). Grade 3 or 4 adverse events occurred in 37% of atezolizumab patients vs 54% of docetaxel patients and were considered related to treatment in 15% vs 43%.

Serious adverse events occurred in 32% vs 31%. Immune-mediated adverse events in patients treated with atezolizumab included pneumonitis hepatitis, and colitis. Adverse events led to treatment discontinuation in 8% vs 19% of patients. Treatment-related death occurred in one patient in the docetaxel group.

By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.